FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Orbit Inserter
K Number: K163400
·
Decision Jul 26, 2017
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
12
Review Days
233
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Basic Information
- Device Name
- Orbit Inserter
- K Number
- K163400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ypsomed AG
- Date Received
- December 5, 2016
- Decision Date
- July 26, 2017
- Product Code
- KZH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
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Other Clearances by Ypsomed AG
| K Number | Device Name | ||
|---|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25 | Aug 28, 2025 | Substantially Equivalent |
| K171984 | Clickfine Pen Needle, Penfine Classic Pen Needle | Oct 11, 2017 | Substantially Equivalent |
| K150921 | Orbit Infusion Set | Apr 12, 2016 | Substantially Equivalent |
| K152514 | Clickfine AutoProtect Pen Needle | Nov 18, 2015 | Substantially Equivalent |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | Jun 9, 2015 | Substantially Equivalent |
| K131125 | CLICKFINE PEN NEEDLE | Jul 5, 2013 | Substantially Equivalent |
| K131123 | CLICKFINE AUTOPROTECT PEN NEEDLE | Jul 5, 2013 | Substantially Equivalent |
| K130468 | ORBIT INFUSION SET | Mar 19, 2013 | Substantially Equivalent |
| K110312 | CLICKFINE AUTOPROTECT PEN NEEDLE | Jan 26, 2012 | Substantially Equivalent |
| K102108 | CLICKFINE PEN NEEDLE | Nov 23, 2010 | Substantially Equivalent |